A total of 96 of 130 opioid-tolerant patients (73.8%) were randomized and took part in a 21(+5)-day open-label, double-blind titration study. The primary endpoint was evaluation of summed pain intensity differences at 30 minutes post-treatment (SPID30), noted Lowell Reynolds, MD, of Loma Linda University, Loma Linda, CA. and colleagues. Safety was assessed throughout the study. Doses of fentanyl SL spray available for the titration and double-blind study periods were 100μg, 200μg, 400μg, 600μg, 800μg, 1200μg, or 1600μg.

Mean (SD) age for the double-blind population was 54.1 (11.7) years. Median (range) dose of fentanyl SL spray in the double-blind period was 800μg (100μg, 1600μg). The most prevalent types of cancer in the study group were reproductive (33%), breast (19%), lung (18%), and head and neck (12% each).

The most frequently reported adverse events (AEs) reported in ≥5% of patients during the titration period included nausea (13.1%), somnolence (8.5%), dizziness (7.7%), vomiting (7.7%), pyrexia (6.2%), diarrhea (5.4%), and peripheral edema (5.4%). In the double-blind period, the most frequently reported AEs were nausea (7.1%), hyperhidrosis (5.1%), and peripheral edema (5.1%). Three deaths were reported; two in the titration period and one in the double-blind period. The investigators noted all deaths were due to underlying disease progression and considered unrelated to study drug. No new safety concerns were identified. Financial support for this study was provided by INSYS Therapeutics.

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